The pharmaceutical industry is concerned with reducing costs to meet the national demands for reasonably priced prescription drugs. One way the pharmaceutical industry is attempting to reduce costs is to modify its current methods of packaging its sterile products. In the past, the packaging of sterile products was accomplished in clean rooms wherein the machines used to package the sterilized product and the personnel necessary to operate the machines are housed. Building, operating and maintaining large clean rooms is quite expensive and significantly contributes to overhead costs.
Thus, a need has arisen for a locally controlled environment wherein a barrier is positioned around the precise area that must be maintained clean so that a reduction in the size of the traditional clean room can be achieved. This results in a savings in capital costs, and the elimination or a reduction in number of people from the clean room, which is the biggest source of contamination.
While locally controlled environments, often referred to as isolation systems, have been known for a number of years, introducing sterilized parts into the isolation system without jeopardizing the sterility of the parts or atmosphere within the isolation system has been problematic. One attempt to solve this problem requires providing a cleaning and sterilizing machine next to the isolation system. The machine includes a hard-walled reusable treatment vessel which receives small articles, such as closure elements for pharmaceutical containers. The containers are sterilized within the treatment vessel and then the treatment vessel is coupled to the isolation system. Prior to passing the closure elements from the treatment vessel to the isolation system, the conduit between the treatment vessel and isolation system is sterilized. After sterilization is complete, the treatment vessel can be accessed to allow the closure elements to be passed through into the isolation system.
However, positioning a cleaning and sterilizing machine proximate to the isolation system, as described above, is also problematic in that it requires the pharmaceutical company to incur the capital costs of purchasing such a cleaning and sterilizing machine and to incur the operation and maintenance costs of such a machine. Therefore, a need has arisen for an inexpensive method of transferring sterilized closure elements to an isolation system.
The present invention provides a combination container for holding sterilized elements and a sterilizable transfer port for transferring the sterilized elements into an isolation system. The container is formed of a flexible bag which receives the sterilized elements and a sealed collar which can be sterilized when it is connected to the isolation system to transfer the elements from the container to the isolation system. The container and transfer port of the present invention is easily used and results in considerable savings in money as well as time in packaging sterilized products for the pharmaceutical industry.